United Kingdom Interdepartmental Liaison Group on Risk Assessment (UK-ILGRA)

Chapter 2

Results of initiatives undertaken during the last two years

ILGRA's work over the past two years has concentrated on four of the
broad areas where the first report identified that greater coherence and consistency in
Departmental approaches to assessing and managing risks should help dutyholders in
fulfilling their duties, while making the Government's approach as a whole look more
cohesive. These are:

the development of more consistent approaches and methodologies for
assessing and managing risks;

improving the way Government communicates about risk;

initiating projects to enable Departments to share their knowledge,
resources and research on risk issues; and

commissioning, financing and steering a number of interdepartmental
research projects on topics of interest to more than one Department.

These initiatives and their outcomes are described below. In addition
a summary of the initiatives and Departments' involvement in them is at Annex 1.

The Development of More Consistent Approaches and
Methodologies

The need for Departments to adopt consistent methodologies for the
assessment and management of risk was highlighted in the first report.This, it was
argued, was necessary because risks rarely apply to a single receptor (eg, the public,
workers) even though the boundaries of responsibility between Departments often appear to
assume that is the case. It is evident that this has caused difficulties, not least for
duty holders who often perceive regulators as adopting different standards for the same
hazards in contexts which are not all that dissimilar.

Since then BRU has undertaken a number of initiatives aimed at
promoting greater convergence towards regulatory best practice. They have published
guidance documents on better regulation including regulatory impact assessments for
Departments to follow when proposing regulations.

However, all Departments agree that much more can and should be done.
ILGRA's approach to the problem has been:

to examine whether it is possible to develop consistent methodologies
and guidelines for risk assessment and risk management across all Departments. In that
context there has been much debate within ILGRA in order to achieve consistency in terms
of similar treatment of similar problems. It was generally agreed (for reasons already
mentioned in para12) that it would be both unreasonable and undesirable to expect
Departments to have identical arrangements in place; and

where approaches are found to be different, to provide Departments
with a forum in which the alternative approaches can be fully described and explanations
given as to why the alternative approaches properly reflect the differing needs for
protection of individuals and society in different areas of regulation.

ILGRA was helped in this work by two sub-groups. Their purposes
andfindings are described below.

Sub-group on Risk Assessment and Toxicology

This sub-group, known as the Risk Assessment and Toxicology Steering
Committee (RATSC), was set up in April 1996 to guide an initiative to review progress and,
in the longer term, to develop and validate innovative approaches to toxicological risk
assessment.

This area was chosen because:

there has been considerable technological progress in the field of
toxicology, for example, new methods such as in vitro studies or comparisons with
toxicity of substances with a similar chemical structure are now available;

the control of exposure to chemicals is of interest to a wide range
of Departments since it impacts on the regulation of food safety, manufacturing processes
in industry, the safety of medicines, products used at home and in the workplace, and
environmental pollution.

RATSC is chaired by the Chief Scientist of the Ministry of
Agriculture, Fisheries and Food (MAFF) and attended by representatives from all those
Departments and Agencies involved in toxicological risk assessment. In line with the above
its aims are:

to review current practice for managing risks to health from toxic
substances, taking into account both UK and overseas experience;

to produce a longer term research strategy to develop and validate
innovative approaches to generating better estimates of risk and improved assessment
procedures; and

to press for new regulations to be risk based, founded on agreed
standards and facilitated through multi-national collaboration in this research programme.

Considerable progress has been made. An exercise mapping current
practices for toxicological risk assessment has been undertaken. Three workshops have been
held aimed at identifying those research areas which will yield better estimates of risk
and improved assessment procedures. The reports of these workshops are being published.
Where possible international consortia will be brought together to fund the research
priorities identified. The outcomes of the research will be used to promote agreement on
improved risk assessment procedures for incorporation into international regulations

Sub Group on the Setting of Safety Standards

This second sub-group of ILGRA is concerned with rather broader
issues. Its members are drawn from Departments but also include academic and industry
advisers. It is chaired by the Treasury. The main purpose of the sub-group is to take
forward the recommendations (see box on page 12) made by the Group on the Setting of
Safety Standards (SSAS) in a sister report to the one produced by ILGRA. The SSAS report
was published in June 1996 and was also endorsed by Ministers.

ain Recommendations of
the SSAS report these were:

a fully rule-based approach to safety regulations, where all
regulations are set according to universal formulae quantifying costs and benefits, would
be unrealistic. Nonetheless common frameworks could and should be developed for all safety
regulations, despite the wide differences in available data and in attitudes towards
different kinds of risks. This would provide a common basis for policy judgement and
standard setting.

Even though the objective of all regulation should be a considered
balance of costs and benefits, in the case of safety regulation, this has sometimes to
include taking into account important ethical constraints.

Although regulation is widely based on the best available scientific
data, there is a need for greater consistency in the extent to which costs of risk
reduction, and the examination of public values and preferences, are taken into account.

The sub-group has taken forward its investigation through a series of
case studies looking critically at how Departments set safety standards, including how far
they adhere to the broad guidelines advocated by BRU in their guidance. The first area
chosen for examination was environmental regulation. A review of DETR's "Guide to
Risk Assessment and Risk Management for Environmental Protection" was already
planned, and it was agreed that this could provide a useful context for the case studies.
Three areas were examined: genetically modified maize; municipal waste incinerators; and
limits for concentrations of benzene in air.

The sub-group has found evidence to support and add weight to the
earlier findings of the SSAS group. Three broad problem areas were identified in the
environmental case studies, but clearly these are also of relevance to other areas of
regulation.

The role Of expert groups
The role of scientific advisers is well established in the regulatory process, largely
through their position on Government advisory committees. However, there is evidence of a
lack of transparency in how experts reach decisions about the levels of risk posed by
particular hazards. The sub-group judged that thought could usefully be given to
clarifying the terms of reference for such groups so as to make clear that their role is
to assist decision makers and not to set standards as such. This would help to ensure and
make apparent that other useful inputs, such as costs and benefits, are also taken into
account in the formulation of policy. This was particularly important. Once an expert
group's judgement on the balance of the scientific arguments is published, pressure may be
created for Government to regulate, even if it is unjustified in cost-benefit terms.

Ensuring that standards adopted reflect the values of society at
large
Even when the above factors are taken into account, policy makers must give due weight
topublic perception of risk. The public themselves hold a wide range of value
judgements and there is scope for improving consultation to take these into account.
Departments therefore need to develop ways of explaining the scientific and policy
background to decisions to the public, and to establish how best to incorporate both
expert judgements and society's preferences into the decision-making process.

Dealing with uncertainty. The group suggested that in
assessing risks where there is considerable uncertainty a clear distinction should be made
between processes that are deterministic (where the cause assures the outcome) and those
which are stochastic (where the outcome depends on chance). Unfortunately, for
environmental risks, it is often the case that though one can readily identify the
deterministic factors that must be present before the risk from a hazard is realised, the
presence of these factors does not automatically mean that the risk will be realised
because whether this happens or not is stochastic in nature. By analogy, one must hold a
lottery ticket (a deterministic condition) to be entered in the draw. But possession of a
ticket cannot guarantee winning a prize because that is a stochastic phenomenon.

Thus in estimating the risk of cancer from exposure to a contaminant
or pollutant, an assessment of the exposure is first made, analogous to the number of
tickets in the draw. However, the development of cancer within those exposed will be
random because several of the critical factors that decide whether a particular individual
develops cancer or not are inherently stochastic in nature.

Failure to distinguish deterministic from stochastic processes can
cause confusion when assessing and managing risks. Thus many risk factors for disease
(diet, lifestyle, exposure) may be known in a deterministic manner, but these factors can
only contribute to the likelihood of the disease because the occurrence of the disease is
stochastic in nature.

The Group suggested that in the cases studied not enough importance
may have been attached to the stochastic processes involved.

The Group also re-iterated the need to identify and assess all
possible options for tackling a particular problem and their merits. As far as the latter
was concerned, they considered that there may be a role for multi-attribute analysis in
choosing between potential options.

Enhancing the UK's Effectiveness in International Negotiations

Most regulations on health, safety and environmental standards these
days emanate from Europe or international fora. Risk assessment increasingly features in
many of these, largely as a result of the success of UK negotiators.

However, a research project undertaken for ILGRA showed that, as in
domestic policy, the absence of a common policy framework for risk assessment and risk
management may be impeding the UK's effectiveness in the negotiation of European and
international standards. The research commissioned for ILGRA, which has now been
completed, assessed whether such a framework would be both desirable and achievable in the
context of international negotiations, and made recommendations for improvement

The review confirmed that there are indeed wide differences within
the UK and the EU in social, institutional, technical and legal approaches to health and
safety and environmental regulation, some of which are justified or sustainable, and
others not.

This is not unexpected given that each policy field has its
established approach, cleared with Ministers and pressed for in European negotiations.
Even so, the criteria used to choose between policy options are often unclear or not made
explicit. A further observation was that the absence of information on the cost or
benefits of implementation of European Directives was an impediment to the evaluation of
outcomes. Such information could usefully help to steer the development of priorities for
regulatory policy.

The review concluded that there was plenty of evidence to suggest
that the likely benefits of greater consistency between Departments would not only
strengthen the UK's position in international negotiations but would also bring benefits
in terms of more constructive debate within Government, better prioritisation and better
communication. A number of recommendations were made, relating to:

progressing towards a common framework for making decisions on risk;

improving communications on negotiations at international level;

steering this work centrally;

the need for common terminology between Departments.

ILGRA will be debating with BRU how best to take forward these
recommendations.

Improving the Way the Government Communicates About Risk

Educating the public about risks from the food they eat, the air they
breathe and the environment in which they live without causing a socio-political response
is a major challenge. This has been brought to the forefront by controversies surrounding
events such as salmonella in eggs, listeria in cheese, blood clots from taking
contraceptives, and anthrax spores in the London Underground - to name but a few.

During the past eighteen months ILGRA has embarked upon an
inter-departmental project to provide guidance to Departments by distilling available good
practice to improve the way risk communication is used to:

promote an informed debate about risks;

produce a constructive interaction at all stages of the
decision-making process;

improve mutual understanding of public and Government attitudes to
policy making about health, safety and the environment;

influence human behaviour in a positive manner.

The main aim has been to derive a set of generic principles for
Government risk communications using the extensive literature available, and to test them
through the examination of Departmental case studies carefully chosen to cover a range of
hazards and contexts. The results are available in a short, condensed guide for officials
involved in communicating on risks, and a report on the results of the research including
details of the case studies. As such the project should also help to recognise good
practice as well as directing and encouraging it.

The case studies have provided a number of useful insights into the
way Departments use communication to develop, achieve and disseminate policy objectives
and respond to concerns about risks. There is ample evidence of good practice,
particularly where risk communication has been acknowledged as a valid policy instrument.
But there are also shortcomings, for example:

it is the exception rather than the rule that communication is
treated as an integral part of risk management policy;

communication is too often seen as one-way information provision;

risk debates are often technical in nature, presenting a barrier to
public inclusion. Moreover, ensuing communications often focus on risk reduction measures
which are unsympathetic to public concerns, with the net result that they do not inspire
confidence and trust;

in certain fields, the provision of independent advice via expert
committees is widely distrusted as part of the system. This may be because some of them
have a history of taking their decisions behind closed doors. Moves towards making
decisions of committees more accessible, such as the publication on the Internet of
agendas and papers, and the widening of representation to include interested parties such
as consumer and environmental groups, are helping to redress the situation while making
further networks accessible for improving communications; and

practice varies widely across and even within Departments.

Four generic principles for successful risk communication have now
been developed to address these shortcomings. The principles and how to implement them are
explained in the guidance document which provides the blueprint for Departments to
benchmark their own practice, identify where they might make improvements and implement
change to suit their own circumstances.

Sharing Knowledge, Resources and the Results of Research on Risk Issues

We pointed out in the first report that facts and data on risks are a
valuable resource. Though the fact that Departments used different information technology
hardware and software was once a major problem, this is no longer the case due to the
availability of operating systems designed to work on most makes and types of information
systems. This development together with a number of initiatives by the Government for
achieving better co-ordination between Departments, such as the provision of an Intranet,
should help achieve the desired objective of better sharing of data amongst Departments.

Deliberations at ILGRA suggest that there will have to be changes in
the culture of Departments before easy cross-accessing of databases between Departments
becomes a reality. In the meantime, ILGRA has put considerable effort into stimulating the
identification of common research needs and the dissemination of information on research
findings with some notable successes. For example, MAFF has taken the lead in compiling a
list of risk related departmental research projects of common interest so that the
findings can be shared throughout Government. Despite some problems in collating the
information, not least because the information was not readily available in a consistent
format, this initiative is providing a useful overview of the research interests across
Government. Departments have now agreed that there would be benefits in keeping the list
up to date, but further resource is needed to collect and compile the information in an
accurate and accessible format.

Other examples of good practice in collaboration do exist, such as
the use of Concordats between Departments, Agencies and Research Councils. The Environment
Agency and HSE, for example, have explored how they might work together more profitably on
research and have (recently) agreed a Concordat. This sets out how they can work together
to identify interests, facilitate interaction, influence Research Councils, and learn from
HSE's experience of research management. Departments also take action to share information
and take views on research strategies, for example, by offering representation on research
groups.

Sharing data and information between Departments on issues other than
research also helps individual Departments to keep up to date with current developments.
The business of ILGRA, including its biannual meetings, has provided a valuable forum for
sharing information and stimulating debate. Presentations to ILGRA, some of which have
been opened to a wider audience, have covered a wide range of methodological issues across
a range of disciplines. Getting the right balance between enhancing understanding and
information overload is not always easy, and it can be difficult to reach the right
people, but ILGRA is taking steps to improve its accessibility by summarising information
and by providing contact points for those who want to know more. Making use of
communications technology, such as the Internet and the Government Intranet, will help.

Identifying, Commissioning, Financing and Steering Research Projects

ILGRA is well placed to identify research where there would be
distinct advantages in inter-departmental collaboration, either because the project can
only be undertaken if Departments are prepared to make available their expertise or the
data they hold, or which would benefit from joint funding because a single Department or
Agency might be reluctant to invest their limited resources in investigating a problem
which spans several others.

Accordingly, a number of projects have been funded across a broad
range of topics and disciplines. We have already mentioned the projects on international
negotiations and the risk communication benchmark study. In addition ILGRA has initiated
the following research projects:

ways of establishing monetary values for avoidance of fatalities
through health and safety measures. This research project, jointly funded by HSE,
Treasury, DETR and the Home Office, will help to improve Departments' cost benefit
analyses of risk reduction measures. It will also provide further information on what
influences people's willingness to pay for reducing risks. So far, it has shown the
benefits of using focus groups to access public opinion on such issues. Emerging results
indicate that people readily accept the idea that policy makers working with limited
resources must make choices between alternative risk reduction measures. This has prompted
further research into the public's attitude to the acceptability of cost-risk trade-offs,
and how these trade-offs are managed and presented.

incorporating expert judgement into decision-making. As a
first step, a small project looked at how decision makers in a range of contexts use
expert judgement. Further research, commissioned by HSE on behalf of a number of
Departments, will analyse current practice for eliciting expert scientific advice or
judgement and incorporating it into policy. The aim is to develop some guiding principles
for establishing good practice. Such principles will benefit from wider dissemination and
discussion.

ways of ranking risks. This critical review of the methods
used to compare and rank risks summarised current practice and suggested broad criteria
for ranking risks and ways of progressing such procedures.